Devices

CDRH Sets 10 Regulatory Science Priorities

CDRH says its 10 FY 2017 regulatory science priorities will be a “catalyst to improving the safety, effectiveness, performance, and quality of medical devices and radiation-emitting products” and will facilitate introducing innovative medical devices into the marketplace. The priorities will be reassessed and updated periodically to reflect current regulatory science needs.

The FY 2017 priorities are:

leverage “big data” for regulatory decision-making;
modernize biocompatibility and biological risk evaluation of device materials;
leverage real-world evidence and employ evidence synthesis across multiple domains in regulatory decision-making;
advance tests and methods for predicting and monitoring medical device clinical performance;
develop methods and tools to improve and streamline clinical trial design;
develop computational modeling technologies to support regulatory decision-making;
enhance the performance of digital health and strengthen medical device cybersecurity;
reduce healthcare-associated infections by better understanding the effectiveness of antimicrobials, sterilization, and reprocessing of medical devices;
collect and use patient input in regulatory decision-making; and
leverage precision medicine and biomarkers for predicting medical device performance, disease diagnosis, and progression.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome